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A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

NCT ID: NCT07255209

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-10-31

Brief Summary

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The study is designed to assess the efficacy and safety of multiple doses of IBI362 in Chinese adolescent subjects with obesity or overweight. It plans to enroll 180 adolescents (aged ≥12 and \<18 years) who have failed to achieve a 5 kg weight reduction after at least 12 weeks of dietary and exercise intervention.

Detailed Description

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Conditions

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Adolescents With Obesity or Overweight With Weight-Related Comorbidities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo SA.QW

IBI362-dose2

Group Type EXPERIMENTAL

IBI362

Intervention Type DRUG

IBI362 SA.QW

IBI362-dose1

Group Type EXPERIMENTAL

IBI362

Intervention Type DRUG

IBI362 SA.QW

Interventions

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Placebo

Placebo SA.QW

Intervention Type DRUG

IBI362

IBI362 SA.QW

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female participants aged ≥12 years and \<18 years at the time of signing the informed consent/assent form.
2. BMI at screening meeting the obesity criteria defined by "WS/T 586-2018 Screening for Overweight and Obesity in School-Age Children and Adolescents" or meeting overweight criteria plus at least one weight-related comorbidity: prediabetes, type 2 diabetes, hypertension, dyslipidemia, fatty liver disease, or obstructive sleep apnea syndrome.
3. Weight change \<5 kg after ≥12 weeks of diet and exercise alone before screening (per self/parental report).

Exclusion Criteria

1. Prior diagnosis of type 1 diabetes.
2. Pre-pubertal participants (Tanner Stage I).
3. History of (or planned) bariatric surgery (except liposuction/abdominoplasty or acupuncture for weight loss performed \>1 year before screening).
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Xiaoyan li

Role: CONTACT

Phone: 18756032014

Email: [email protected]

Facility Contacts

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Junfen Fu

Role: primary

Other Identifiers

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CIBI362B304

Identifier Type: -

Identifier Source: org_study_id